Pharma Techexplained
Glossary

ERES

Electronic records, electronic signatures. The subject matter of 21 CFR Part 11.

ERES is the umbrella term for the two things Part 11 regulates: records kept electronically in place of paper, and signatures executed electronically in place of ink. The rule's purpose is equivalence, ensuring an electronic record can be trusted at least as much as the paper one it replaced.

The term shows up most often in vendor documentation and assessment checklists, where an ERES assessment means determining which records and signatures in a system actually fall under the rule, a scoping exercise governed by the predicate rules.